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Approving Medicines in Australia

There are two important regulatory bodies in Australia involved in the
approval and use of medicines called the Therapeutic Goods Administration and
the Pharmaceutical Benefits Scheme and we will take a look at how they both
work to approve new medicines.

Therapeutic Goods Administration
(TGA) of Australia

The TGA is Australia’s regulatory authority for therapeutic goods such
as medicines. TGA carry out a range of
assessment and monitoring activities to ensure medicines available in Australia
are of an acceptable standard with the aim of ensuring that the Australian
community has access within a reasonable time frame to these medicines and is a
requirement by Australian law. The TGA
must approve a medicine for a certain indication before it can be listed on the
Pharmaceutical Benefits Scheme. You can
go online to the TGA website to search for a medicine by name to see if it is
approved for use in Australia.

The PBS is part of the Australian Government’s National Health Policy
and they provide timely, reliable and affordable access to medicines for
Australians. Under the PBS, the
government subsidises the cost of a medicine for most medical conditions so
that Australians do not have to afford the entire cost of the medicine and
instead pays a smaller fraction of the cost which makes medicines more
affordable to the Australian public. You
can go online to the PBS website listed below to search for a medicine by name
to see if it is currently covered by the PBS.

The PBS have an advisory committee of independent expert individuals
called the Pharmaceutical Benefits Advisory Committee (PBAC). PBAC have a process they follow by which
medicines are reviewed for listing on the PBS. PBAC make recommendations to the government about whether to subsidise
new medicines or not and then the government makes the decision of whether to
subsidise the new medicine on the PBS.

What is the application process
for getting a new medicine approved by the PBS?

PBAC meet three times a year in March, July and November to review submissions
for listing on the PBS and the key steps to submission of a medicine are as
follows;

The sponsor of the medicine (normally the pharmaceutical company) makes
a submission for a medicine to the PBAC four months prior to the PBAC meeting
date

The PBAC agenda listing all submissions is published 10 weeks prior to
the meeting

Members of the public and health professionals can submit comments
about the submissions to the PBAC from the date of the agenda is published up
until 4 weeks prior to the meeting

PBAC recommendations are published 6 weeks after the meeting

If the PBAC rejects a submission it will explain why and the sponsor of
the medicine can resubmit if they can address the PBAC’s concerns

Under special circumstances, the government may agree to subsidise the
cost of a medicine on a provisional basis. This process is known as the ‘Managed Access Program’ and PBAC may agree
to this access program under the following circumstances;

Where patients have an urgent clinical need for a medicine

There is enough clinical evidence to show the benefit of the medicine
but not enough to demonstrate cost-effectiveness

Where the sponsor of the medicine will be able to provide more clinical
evidence in a reasonable time period so that the PBAC can undertake a full
assessment of the medicines value

The ‘Managed Access Program’ does not guarantee that a medicine will be
approved for listing on the PBS indefinitely either as PBAC may recommend
delisting of the medicine based on the further clinical evidence provided about
the efficacy and safety of the medicine

How can patients have a say in
the PBAC review process for PBS?

Anyone is the Australian public who has an interest in a certain
medicine and the decision on whether it should be subsidised on the PBS is able
to have their voice heard. This includes
those people living with the disease, a loved one who has been impacted by the
disease, members of the public, carers, family members, friends, health care
professionals and patient consumer groups.

Consumer involvement from patients allows the submission for a certain
medicine to demonstrate how the availability of that particular medicine on the
PBS would impact an individual’s quality of life and most importantly how not
being able to access the medicine would disadvantage an individual.

Where patients have an urgent clinical need for a medicine

There is enough clinical evidence to show the benefit of the medicine
but not enough to demonstrate cost-effectiveness

Where the sponsor of the medicine will be able to provide more clinical
evidence in a reasonable time period so that the PBAC can undertake a full
assessment of the medicines value

The ‘Managed Access Program’ does not guarantee that a medicine will be
approved for listing on the PBS indefinitely either as PBAC may recommend
delisting of the medicine based on the further clinical evidence provided about
the efficacy and safety of the medicine

How can patients have a say in
the PBAC review process for PBS?

Anyone is the Australian public who has an interest in a certain
medicine and the decision on whether it should be subsidised on the PBS is able
to have their voice heard. This includes
those people living with the disease, a loved one who has been impacted by the
disease, members of the public, carers, family members, friends, health care
professionals and patient consumer groups.

Consumer involvement from patients allows the submission for a certain
medicine to demonstrate how the availability of that particular medicine on the
PBS would impact an individual’s quality of life and most importantly how not
being able to access the medicine would disadvantage an individual.

The PBAC meeting agenda with the list of medicines for submission can
be found on the PBS website and you can make comments on a form on the
following website link;

What happens after the PBAC make
a recommendation for medicines to be listed on the PBS?

The Health Minister (or delegate) considers the PBAC’s recommendations
and the Health Department’s advice on the cost of the medicine to the PBS which
is developed through the negotiations with the medicine’s sponsor.

The decision to subsidise a medicine goes to the cabinet if the cost of
the medicine is expected to be in excess of 20 million dollars a year to the
PBS. If the cabinet approves the subsidy
the decision on the timing to add the medicine to the PBS is decided by the
Health Minister. The timing of these
reviews by cabinet can vary but may take up to 6 months from the PBAC’s
recommendations.

How can a patient gain access to
a medicine prior to registration or subsidy on the PBS?

Patients may be able to access a medicine prior to it being approved by
the TGA on a clinicl trial or by a ‘Special Access Scheme’. The ‘Special Access Scheme’ enables doctors
to apply for a medicine for their patient when they have exhausted all other
approved treatment options and more information on this scheme can be found on
the TGA website by following this website link;

Some pharmaceutical companies also offer ‘Patient Access Programs’ for
medicines approved by the TGA but awaiting PBS listing. Doctors can apply for a patient to receive a
medicine on these programs and the patient eligibility is determined by the
pharmaceutical company and there may be a cost of the medicine incurred by the
patient. Pharmaceutical companies in
Australia are guided by the Code of Conduct and are therefore limited with the
information that they can provide directly to patients. If you are wondering if there is are any
other medicines out there that may help you in the treatment of your lymphoma
do not be afraid to ask your doctor or nurse for further information.

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